Hemorrhage and/or Microaneurysm Severity and Count in Ultrawide Field Images and Early Treatment Diabetic Retinopathy Study Photography.

OBJECTIVE: To evaluate detection of hemorrhage and/or microaneurysm (H/Ma) using ultrawide field (UWF) retinal imaging as compared with standard Early Treatment Diabetic Retinopathy Study (ETDRS) 7-field photographs (ETDRS photos). DESIGN: Single-site comparative study of UWF images and ETDRS photos. PARTICIPANTS: One hundred twenty-six eyes of 69 patients with no diabetic retinopathy (DR) or mild or moderate nonproliferative DR (NPDR). METHODS: Stereoscopic 200° UWF images and stereoscopic 35mm 30° 7-field color photographs were acquired on the same visit. Images were graded for severity and distribution of H/Ma. H/Mas were counted in ETDRS fields 2 to 7 in both ETDRS photos and UWF images. H/Mas in the UWF peripheral fields were also counted. MAIN OUTCOME MEASURES: Kappa (κ) and weighted κ statistics for agreement. Number of H/Ma within and outside ETDRS fields identified in UWF images and ETDRS photos. RESULTS: Distribution of DR severity by ETDRS photos was 24 (19.0%) no DR, 48 (38.1%) mild NPDR, and 54 (42.9%) moderate NPDR. A total of 748 of 756 fields (98.9%) were gradable for H/Mas on ETDRS photos and UWF images. Simple κ/weighted κ statistics for severity of H/Ma: all fields 0.61/0.69, field 2 0.70/0.77, field 3 0.62/0.73, field 4 0.50/0.62, field 5 0.54/0.65, field 6 0.64/0.70, and field 7 0.58/0.63 with overall exact agreement in 81.3% and within 1 step in 97.9% of fields. A greater proportion of fields was graded a more severe H/Ma level in UWF images than in the corresponding ETDRS photos (UWF: 12.7% vs. ETDRS: 6.5%). Evaluating comparable areas in UWF images and ETDRS photos (fields 2-7), a mean of 42.8 H/Mas were identified using ETDRS photos and 48.8 in UWF images (P = 0.10). An additional mean of 21.3 H/Mas (49.8% increase, P < 0.0001) were identified in the peripheral fields of the UWF images. CONCLUSIONS: There is good to excellent agreement between UWF images and ETDRS photos in determining H/Ma severity, with excellent correlation of H/Ma counts within ETDRS photo fields. UWF peripheral fields identified 49.8% more H/Ma, suggesting a more severe H/Ma in 12.7% of eyes. Given the additional lesions detected in peripheral fields and the known risks associated with H/Ma and peripheral lesions, quantification of H/Ma using UWF images may provide a more accurate representation of DR disease activity and potential greater accuracy in predicting DR progression.